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Director, CMC Regulatory Affairs

Larimar TherapeuticsBala Cynwyd, Pennsylvania, United States, 19004

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Description : About Us :

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC.

Our company’s strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team’s know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!

Position Summary :

Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director.

Job Duties / Responsibilities :

Larimar Team Membership

The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team.
Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar.
Works closely with RA Sr. Director and serve as backup to other global regulatory activities

Strategy, Guidance

Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects

Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements

Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes.

CMC Documentation, Submissions and HA interactions

Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar’s regulatory submission timing and strategy

With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting.

Requirements :

Key Experience, Skills and Knowledge :

Minimum of 4-year undergraduate degree

10+ years’ experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred

Understanding of GxP systems and Quality principles

Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies.

Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions

Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications.

Excellent communication, time management and project management skills

Continuous quality improvement mindset and attention to details

Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model.

Can do attitude, flexibility, and mental agility

Benefits :

Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

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Director Regulatory Cmc • Bala Cynwyd, Pennsylvania, United States, 19004